BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2023539 · Received March 16, 2011

    Report

    Report Number
    3003603429-2011-00012
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 16, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. DISTAL EMBOLIZATION IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SYSTEM AND IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. THE DEVICE WAS NOT USED PER THE IFU. THE GUIDEWIRE USED IN THIS CASE WAS AN EMBOSHIELD FILTER GUIDEWIRE WHICH IS NOT A COMPATIBLE ACCESSORY AND THE IFU INCLUDES A CAUTION REGARDING THE USE OF THE GUIDEWIRES NOT LISTED FOR USE, "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM G3 SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SYSTEM."

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A DISTAL LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS USED FOR A TOTAL OF 2-3 MINUTES. AFTER TREATING THE DISTAL SFA, THE PATIENT HAD NO REFLOW IN TWO TIBIAL VESSELS AND REQUIRED AN INTERVENTION. THE PHYSICIAN USED AN EXPORT CATHETER AND BALLOON TO TREAT THE DISTAL EMBOLIZATION. UPON EXAMINATION A FEW DAYS POST PROCEDURE, THE PATIENT WAS DOING WELL AND DID NOT REQUIRE FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention